Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material 678882

GUDID D00267888282

Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material Cartridge Refill Package

DENTSPLY INTERNATIONAL INC.

Silicone dental impression material

• Primary Device ID: D00267888282
• NIH Device Record Key: cbc4ddcd-144c-4ab4-a9fc-e47a071c28b2
• Commercial Distribution Discontinuation: 2021-07-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material
• Version Model Number: 678882
• Catalog Number: 678882
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 4
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026788820 [Unit of Use]
HIBCC	D0026788821 [Primary]
HIBCC	D00267888282 [Package]; Contains: D0026788821; Package: Box [8 Units]; Discontinued: 2021-07-05; Not in Commercial Distribution

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-01-25
• Device Publish Date: 2016-09-21

On-Brand Devices [Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material]

• D00267888282: Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material Cartridge Refill Package
• D0026789700: Aquasil Ultra XLV Fast Set 50 ML Single
• D002678870122: Aquasil Ultra XLV Fast Set 2-Pack Cartridge Refill Case (12)